8 results
·
20ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
SeaSpine Shoreline ACS - Anterior Cervical Standalone System
FDA 510(k)
FDA Class 2
·Orthopedic
MERIT EMBOLECTOMY CATHETER MODEL ASAP100
FDA 510(k)
FDA Class 2
·Cardiovascular
SM INTERNAL./EXTERNAL IMPLANT SYSTEM
FDA 510(k)
FDA Class 2
·Dental
RESTORE ULTRA
FDA Adverse Event
Injury
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·October 14, 2014
COLLEAGUE PRE P1.7
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 21, 2011
HEARTSTART MRX-EMS DEFIBRILLATOR
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·May 28, 2013
DRIVE SHAFT-MINIMUM 520MM LENGTH-FOR USE WITH RIA
FDA Adverse Event
Malfunction
·SYNTHES MONUMENT·Product code HTO·October 1, 2013
Reamer / Irrigator / Aspirator (RIA): RIA Drive Shafts, RIA Tube Assemblies, sterile, RIA Reamer Head, sterile (12.0mm-19.0mm); intended to clear the medullary canal of bone marrow and debris and to effectively size the medullary canal for the acceptance of an intramedullary implant or prosthesis
FDA Enforcement
Class II
·Terminated·Synthes, Inc.·July 22, 2015